(54 days)
SCENARIA Phase 2 (K123509)
No
The summary describes standard CT technology and image processing techniques (MPR, volume rendering, CTA) without mentioning any AI or ML components.
No
The device is described as an imaging system used to acquire and post-process medical images for diagnostic aid, not for therapeutic purposes.
Yes
The device produces images and post-processed data (like CT angiography, MPR, and volume rendering) which are explicitly stated to "provide an aid to diagnosis when used by a qualified physician." This aligns with the definition of a diagnostic device.
No
The device description explicitly lists hardware components such as a Gantry, Operator's Workstation, Patient Table, and High-Frequency X-ray Generator, indicating it is a hardware system with integrated software, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Supria system is an X-ray Computed Tomography (CT) system. It uses X-rays to create cross-sectional images of the body. This is an in vivo imaging technique, meaning it is performed on a living organism, not on samples taken from the body.
- Intended Use: The intended use clearly states it is for "head, whole body, and vascular X-ray Computed Tomography applications." This involves imaging the patient directly.
- Device Description: The description details the components and operation of a CT scanner, which is consistent with an in vivo imaging device.
Therefore, the Supria system falls under the category of medical imaging devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Supria system is indicated for head, whole body, and vascular X-ray Computed Tomography applications in patients of all ages. The images can be acquired in either axial, helical, or dynamic modes.
The volume datasets acquired by the Supria can be post processed by the system to provide additional information. Post processing capabilities included in the Supria software include CT angiography (CTA). Multi-planar reconstruction (MPR) and volume rendering.
Volume datasets acquired by the Supria can be transferred to external devices via a DICOM standard interface. The guideShot Option adds a remote in-room display and controls to support interventional imaging. The device output can provide an aid to diagnosis when used by a qualified physician.
Product codes
JAK
Device Description
The SUPRIA is a multi-slice computed tomography system designed to perform multi-slice CT scanning supported by 16-detector technology. The system allows optimum clinical applications ranging from routine exams in response to the diversified circumstances in imaging whole body regions.
The SUPRIA system uses 16-slice CT technology, where the X-ray tube and detector assemblies are mounted on a frame that rotates continuously around the patient using slip ring technology. The solid-state detector assembly design collects up to 16 slices of data simultaneously. The X-rav sub-system features a high frequency generator. X-ray tube, and collimation system that produces a fan beam X-ray output. The system can operate in a helical (spiral) scan mode where the patient table moves during scanning. As the X-ray tube/detector assembly rotates around the patient, data is collected at multiple angles. The collected data is then reconstructed into cross-sectional images by a high-speed reconstruction sub-system. The images are displayed on a Computer Workstation, stored, printed, and archived as required. The workstation is based on current PC technology using the Windows™ operating system.
The SUPRIA system consists of a Gantry, Operator's Workstation, Patient Table, High-Frequency X-ray Generator, and accessories.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray Computed Tomography
Anatomical Site
head, whole body, and vascular
Indicated Patient Age Range
all ages
Intended User / Care Setting
qualified physician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Testing - Clinical: Using a phantom, clinical images have been provided which confirm the SUPRIA w/guideShot Option has equivalent basic performance as the predicate device, SCENARIA Phase2.
Performance Testing - Bench: Additional bench performance testing was determined to be unnecessary do to the fact no technological changes have occurred since the original submission except the addition of the guideShot feature to the SUPRIA.
Clinical images were collected and analyzed to ensure that the SUPRIA w/guideShot Option will meet user needs. Clinical image examples were provided and judged to be sufficient for clinical usability.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
SCENARIA Phase 2 Whole-body X-ray CT System (K123509)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of three human profiles facing right, stacked on top of each other, with flowing lines above them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 17, 2016
Hitachi Medical Systems America, Inc. % Mr. Doug Thistlethwaite Manager of Regulatory Affairs 1959 Summit Commerce Park TWINSBURG OH 44087
Re: K161748
Trade/Device Name: SUPRIA w/ guideShot Option Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: June 16, 2016 Received: June 24, 2016
Dear Mr. Thistlethwaite:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21. Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael O'Hara
For
Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K161748
Device Name SUPRIA w/ guideShot Option
Indications for Use (Describe)
The Supria system is indicated for head, whole body, and vascular X-ray Computed Tomography applications in patients of all ages. The images can be acquired in either axial, helical, or dynamic modes.
The volume datasets acquired by the Supria can be post processed by the system to provide additional information. Post processing capabilities included in the Supria software include CT angiography (CTA). Multi-planar reconstruction (MPR) and volume rendering.
Volume datasets acquired by the Supria can be transferred to external devices via a DICOM standard interface. The guideShot Option adds a remote in-room display and controls to support interventional imaging. The device output can provide an aid to diagnosis when used by a qualified physician.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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3
Section 5
510(k) Summary
4
| Submitter Information | |
|---|---|
| Submitter: | Hitachi Medical Systems America, Inc. |
| 1959 Summit Commerce Park | |
| Twinsburg, Ohio 44087-2371 | |
| Contact: | Douglas J. Thistlethwaite |
| Telephone number: | 330-425-1313 |
| Telephone number: | 330-963-0749 |
| E-mail: | thistlethwaited@hitachimed.com |
| Date: | June 16, 2016 |
Submitter Information
Device Name
| Regulation Number: | 21 CFR 892.1750 |
|---|---|
| Regulation Name: | Computed tomography x-ray system |
| Product Code | JAK, System, X-Ray, Tomography, Computed |
| Class | II |
| Panel | Radiology |
| Trade/Proprietary Name: | SUPRIA w/guideShot Option |
| Predicate Device(s): | SCENARIA Phase 2 Whole-body X-ray CT System (K123509) |
Device Intended Use
The SUPRIA system is indicated for head, whole body, and vascular X-ray Computed Tomography applications in patients of all ages. The images can be acquired in either axial, helical, or dynamic modes.
The volume datasets acquired by the SUPRIA can be post processed by the system to provide additional information. Post processing capabilities included in the SUPRIA software include CT angiography (CTA), Multi-planar reconstruction (MPR) and volume rendering.
Volume datasets acquired by the SUPRIA can be transferred to external devices via a DICOM standard interface.
The guideShot Option adds a remote in-room display and controls to support interventional imaging. The device output can provide an aid to diagnosis when used by a qualified physician.
Device Description
Function
The SUPRIA is a multi-slice computed tomography system designed to perform multi-slice CT scanning supported by 16-detector technology. The system allows optimum clinical applications ranging from routine exams in response to the diversified circumstances in imaging whole body regions.
Scientific Concepts
The SUPRIA system uses 16-slice CT technology, where the X-ray tube and detector assemblies are mounted on a frame that rotates continuously around the patient using slip ring technology. The solid-state detector assembly design collects up to 16 slices of data simultaneously. The X-rav sub-system features a high frequency generator. X-ray tube, and collimation system that produces a fan beam X-ray output. The system can operate in a helical (spiral) scan mode where the patient table moves during scanning. As the X-ray tube/detector assembly rotates around the patient, data is collected at multiple angles.
5
The collected data is then reconstructed into cross-sectional images by a high-speed reconstruction sub-system. The images are displayed on a Computer Workstation, stored, printed, and archived as required. The workstation is based on current PC technology using the Windows™ operating system.
Physical and Performance Characteristics
The SUPRIA system consists of a Gantry, Operator's Workstation, Patient Table, High-Frequency X-ray Generator, and accessories. The system performance is similar to the predicate device.
Performance Comparison
A clinical evaluation comparison was conducted with the SUPRIA quideShot system and the SCENARIA Phase 2 quideShot System (K123509) and found to be substantially equivalent.
A rationale analysis was then conducted and the results are contained in Table 1.
| Table 1 Performance Comparison Analysis | |
|---|---|
| ----------------------------------------- | -- |
| Testing Type | Rationale Analysis |
|---|---|
| Performance Testing - Clinical | Using a phantom, clinical images have been provided which confirm the SUPRIA w/guideShot Option has equivalent basic |
| performance as the predicate device, SCENARIA Phase2. | |
| Performance Testing - Bench | Additional bench performance testing was determined to be unnecessary do to the fact no technological changes have |
| occurred since the original submission except the addition of the guideShot feature to the SUPRIA. |
The analysis confirms the performance characteristics of the SUPRIA are comparable to the predicate device and support our conclusion that the SUPRIA system is substantially equivalent.
Device Technological Characteristics
The following comparison tables are exactly the same as those submitted with the original SUPRIA submission (K150565) except the guideShot feature is now available on the SUPRIA.
| ITEM | SUPRIA w/guideShot Option | SCENARIA Phase 2 Whole-body
X-ray CT System (K123509) | Difference Analysis |
|--------------------------------------------------------------|---------------------------------------------------------|-------------------------------------------------------------|---------------------|
| Gantry | | | |
| Geometry | Rotate-rotate with offset detector
system, slip ring | Rotate-rotate with offset detector
system, slip ring | No |
| Scan Time | 0.75, 1.0, 1.5, 2.0 [s] | 0.35, 0.4, 0.5, 0.75, 1.0, 2.0 [s] | Table 3: 01 |
| X-ray Fan Beam Angle | 51 [deg] | 51 [deg] | No |
| Gantry Tilt | -30 to +30 [deg] | -30 to +30 [deg] | No |
| Gantry Aperture | 750 [mm] | 750 [mm] | No |
| Gantry Dimensions | 1990 x 920 x 1842.5 [mm] | 2350 x 880 x 2030 [mm] | Table 3: 02 |
| Gantry Weight | 1600 [kg] | 2235 [kg] | Table 3: 02 |
| Scan Localizer | Laser | Laser | No |
| Detector | | | |
| Type | Solid state | Solid state | No |
| Number of Channels | 880 [ch] (8ch reference) | 888 [ch] (8ch reference) | Table 3: 03 |
| Number of Rows | 16 | 64 | Table 3: 03 |
| Number of Slices | 16 [slice/scan] (Axial) | 64, 128 [slice/scan] (Axial) | Table 3: 03 |
| X-ray Tube | | | |
| Anode Heat Storage | 5 [MHU] | 7.5 [MHU] | Table 3: 04 |
| Dissipation Rate | 470 [kHU/min] | 1,386 [kHU/min] | Table 3: 04 |
| Tube cooling | Oil/air | Cooling Fluid/air | Table 3: 04 |
| Tube focal spot | Dual 0.7 x 0.8, 1.2 x 1.4 [mm] | Dual 0.7 x 0.8, 1.2 x 1.4 [mm] | No |
| ITEM | SUPRIA w/guideShot Option | SCENARIA Phase 2 Whole-body
X-ray CT System (K123509) | Difference Analysis |
| X-ray Generator | | | |
| kW Output | System Maximum 48[kW] /
Generator Maximum 51 [kW] | 72 [kW] | Table 3: 05 |
| Max. Power Input | 75 [kVA] | 100 [kVA] | Table 3: 05 |
| kVp Range | 80, 100, 120, 140 [kVp] | 80, 100, 120, 140 [kVp] | No |
| mA Range | 10 to 400 [mA] @120kV, 48kW | 10 to 600 [mA] @120kV, 72kW | Table 3: 05 |
| Patient Table | | | |
| Range of Movement,
Vertical | 450 to 1000 [mm] (CT-WT-21) | 465 to 1050 [mm] (CT-WT-19)
450 to 1050 [mm] (CT-WT-18L) | Table 3: 06 |
| Range of Movement,
Longitudinal | 1910 [mm] (CT-WT-21) | 2110 [mm] | Table 3: 06 |
| Range of Movement,
Lateral | N/A | -80 to +80 [mm] (CT-WT-19) | Table 3: 06 |
| Scannable Range | 155 cm | 175 cm | Table 3: 06 |
| Maximum Load Capacity | 227 [kg] | 230 [kg] | Table 3: 06 |
| Display | | | |
| Monitor Type | 24" LCD | 24" LCD | No |
| Matrices, Pixels | 1920 x 1200 | 1920 x 1200 | No |
| Image Enlargements | Up to 9.99x | Up to 9.99x | No |
| Max. Slices Displayed at Once | 25 | 25 | No |
| Image Storage | | | |
| Hard Disk | 110 [GB] (images),
200 [GB] (raw data) | 250 [GB] (images),
750 [GB] (raw data) | Table 3: 07 |
| Storage Images | 200,000 | 200,000 | No |
| Archival Storage (Media) | DVD-R/RW, CD-R/RW | DVD-RAM, DVD-R/RW,
CD-R/RW | Table 3: 07 |
| Scanning, Reconstruction | | | |
| Localization Scan | Real time | Real time | No |
| Localization Scan Length | 150, 250, 350, 500, 750,
1000, 1250, 1500, 1750 [mm] | 150, 250, 350, 500, 750,
1000, 1250, 1500, 1750 [mm] | No |
| Max. Scan Time | 100 [s] | 100 [s] | No |
| Helical Beam Pitch | 0.56, 0.81, 1.06, 1.31, 1.56 | 0.58, 0.83, 1.08, 1.33, 1.58
@40mm Collimation | Table 3: 08 |
| Collimation | 1.25, 5, 10 [mm] | 1.25, 5, 10, 15, 20, 40 [mm] | Table 3: 08 |
| Reconstruction Matrix | 512 x 512 [pix] | 512 x 512 [pix] | No |
| Reconstruction FOVs | 20 to 500 [mm] | 20 to 500 [mm] | No |
| Slice Thickness | 0.625, 1.0, 1.25, 2.5, 3.75,
5.0, 7.5, 10.0 [mm] | 0.625, 1.0, 1.25, 2.5, 3.75,
5.0, 7.5, 10.0 [mm] | No |
| Range of CT numbers | -2000 to +4000 (13bit)
-32768 to +32767 (16bit) | -2000 to +4000 (13bit)
-32768 to +32767 (16bit) | No |
| Reconstruction Time | 0.1 seconds per image or less | 0.2 seconds per image or less | Table 3: 09 |
| Performance | | | |
| High-contrast spatial resolution | 0.35 [mm] | 0.35 [mm] | No |
| Low-contrast resolution mm at % at ≤4
rads | 2.5 [mm] @ 0.25% | 2.5 [mm] @ 0.25% | No |
| 10% MTF | 15.1 [lp/cm] | 15.1 [lp/cm] | No |
| 50% MTF | 12.1 [lp/cm] | 12.1 [lp/cm] | No |
| Dose Controls | | | |
| Bow Tie Filter | Yes. Normal | Yes. Small / Normal | Table 3: 10 |
| Automatic Exposure Control | Yes. IntelliEC | Yes. IntelliEC | No |
| Longitudinal Modulation | Yes | Yes | No |
| Angular Modulation | Yes | Yes | No |
| Iterative Reconstruction | Yes. Intelli IP Advanced Mode | Yes. Intelli IP Advanced Mode | No |
| Maximum possible pitch with full image
quality | 1.56 | 1.58 | Table 3: 11 |
| ITEM | SUPRIA w/guideShot Option | SCENARIA Phase 2 Whole-body
X-ray CT System (K123509) | Difference Analysis |
| Dose Displays | | | |
| CTDIv | Yes | Yes | No |
| DLP | Yes | Yes | No |
| Features | | | |
| Axial Scan | Yes | Yes | No |
| Helical Scan | Yes | Yes | No |
| Dynamic Scan | Yes | Yes | No |
| Predict Scan | Yes | Yes | No |
| ECG Retrospective Scan
(Helical) | No | Yes | Table 3: 12 |
| ECG Prospective Scan
(Axial) | No | Yes | Table 3: 12 |
| guideShot Scan | Yes | Yes | No |
| Automatic Exposure Control | Yes. | Yes. IntelliEC | No |
| Automatic Exposure Control using Iterative
Reconstruction | No. | No. | No |
| ECG Dose Modulation | No | No. | No |
| Adaptive Filter | No | Yes. Intelli IP Normal | Table 3: 13 |
| Iterative Reconstruction | Yes. Intelli IP Advanced | Yes. Intelli IP Advanced | No |
| Injector Synchronization | Yes | Yes | No |
| Dose Check | Yes | Yes | No |
| Access Control | Yes | No | Table 3: 14 |
| Automatic Cardiac Phase Search | No | Yes. CardioHarmony | Table 3: 12 |
| Preview Scan | No | No | No |
| Double Slice at Axial Scan | No | Yes. Fine Recon | Table 3: 15 |
| Priority Recon. | No | No | No |
| Dose Report | Yes. Simple Dose Report | Yes. Simple Dose Report | No |
| DICOM | Yes | Yes | No |
| ID Reader | Yes | No | Table 3: 16 |
| Exam Split | Yes | No | Table 3: 17 |
| Multi-Planar Reconstruction (MPR) | Yes | Yes | No |
| Volume Rendering | Yes | Yes | No |
| CT Angiography (CTA) | Yes | Yes | No |
| Segmentation | Yes | Yes | No |
| Retouch | Yes | Yes | No |
| Quality Exam | Yes | No | Table 3: 18 |
Table 2 Technological Characteristic Differences
5-3
6
7
The differences from the predicate device to SUPRIA are explained in Table 3.
Table 3 Analysis of Differences
| Gantry | |
|---|---|
| 01 | Because the specifications of the device are different, the minimum scan time of this device is not as short as the Predicate. This |
| change does not affect overall technological characteristics compared to the Predicate. | |
| 02 | Because the specifications of the device are different, the size and the weight of the Gantry of this device are different from the |
| Predicate. However, as the device weighs less and has a smaller footprint than the Predicate, we judge that these changes do not | |
| impact the intended use. | |
| Detector | |
| 03 | Because the number of provided slices for one rotational scan is different per equipment specifications, there are fewer number of |
| detectors and number of the channels than the Predicate. | |
| X-ray Tube | |
| 04 | The X-ray tube of this device is different from Predicate only in heat capacity. The X-ray tube focal spot and general performance |
| characteristics are the same as the Predicate. |
8
| X-ray Generator | |
|---|---|
| 05 | The X-ray generator was selected to match the performance specifications of this device and conforms to IEC60601-2-44-2009 requirements for CT systems. The kVp and mA output of the device is comparable to the Predicate. |
| Patient Table | |
| 06 | The scannable range specification was defined assuming the number of the provided slices by one rotational scan is approximately 25% of Predicate, and the table travel and weight capacity specifications are generally equivalent to the Predicate. |
| Image Storage | |
| 07 | The data output volume of this device is approximately 25% of Predicate and the volume of the hard disk drive (HDD) was defined to give an equivalent exam capacity as the Predicate. |
| In addition, we select commonly available external output media that is both easy to obtain and meets the device specification requirements. | |
| Scanning, Reconstruction | |
| 08 | The helical scan pitch specification is based on the table movement distance and collimation width, but is nearly identical to the Predicate. |
| 09 | The data processing load of this device is approximately 25% of Predicate and the computing capacity was defined to achieve an equivalent performance specification compared to the Predicate. |
| Dose Controls | |
| 10 | While this device is not equipped with a small Bow-Tie Filter, the normal Bow-Tie Filter provides generally equivalent performance to the Predicate and does not substantially impact the effectivity and safety of this device. |
| 11 | As noted above, the pitch specification is only marginally different and therefore does not substantially alter the device performance as compared to the Predicate. |
| Features | |
| 12 | This device is a general purpose CT system that is not equipped with an ECG function. The lack of ECG does not substantially affect the intended use of the device and does not impact the effectivity and safety of this device as compared to the Predicate. |
| 13 | This device is not equipped with an Adaptive Filter function, but has an Iterative Reconstruction feature which provides an equivalent image processing function. |
| 14 | This function is intended to confirm device performance according to IEC 62351-8 and NEMA XR-26. |
| 15 | This device is not equipped with a Fine Recon function which does not impact the effectivity and safety of this device. |
| 16 | This function supports the input of patient information by a bar code reader. |
| 17 | This function is for dividing one examination into multiple examinations (with unique Accession numbers) as an operator convenience. |
| 18 | This function is intended to confirm device performance according to IEC 61223-3-5/IEC 61223-2-6. |
Therefore, based on a thorough analysis and comparison of the SUPRIA and the predicate device, the technological characteristics do not impact safety and effectiveness.
9
Substantial Equivalence
A summary decision was based on analysis of Table 4.
Table 4 Rationale Analysis: SUPRIA vs. Predicate
| ITEM | Overall Rationale Analysis |
|---|---|
| Gantry | |
| Detector | Different specifications do not constitute a new intended use. There are no significant changes in technological |
| characteristics. The gantry and detector design was based on the same technology as the Predicate. These sub-systems | |
| have the same level of general effectiveness as the Predicate based on the performance test results shown in Section 10. | |
| X-ray Tube | For safety, these items are controlled and tested according to same regulations and/or standards as the Predicate. |
| X-ray | |
| Generator | This item conforms to IEC60601-2-44-2009 requirements for CT systems and has the same level of general effectiveness |
| as the Predicate based on the performance test results shown in Section 10. For safety, this item is controlled and tested | |
| according to same regulations and/or standards as the Predicate. | |
| Patient Table | Different specifications do not constitute a new intended use. There are no significant changes in technological |
| characteristics. The table travel and weight capacity characteristics are generally equivalent to the Predicate. For safety, | |
| this item is controlled and tested according to same regulations and/or standards as the Predicate. | |
| Display | There are no functional differences in this item. |
| Image Storage | Different specifications do not constitute a new intended use. There are no significant changes in technological |
| Scanning, | |
| Reconstruction | characteristics. The design criteria for these elements were set to allow comparable performance to the Predicate. The |
| performance of these sub-systems does not substantially affect the effectivity and safety as compared to the Predicate and | |
| were verified by design V&V1. | |
| Performance | There are no substantial differences in this category based on the performance test results from the original submission. |
| Dose Controls | Different specifications do not constitute a new intended use. There are no significant changes in technological |
| characteristics. For safety, these items are controlled and tested according to same regulations and/or standards as the | |
| Predicate. | |
| Dose Displays | There are no functional differences in this item. |
| Features | Different specifications do not constitute a new intended use. There are no significant changes in technological |
| characteristics and the feature set of the device is generally equivalent to the Predicate. |
Therefore, based on a thorough analysis and comparison of the functions, scientific concepts, physical and performance characteristics, performance comparison and technological characteristics, the proposed SUPRIA w/guideShot Option is considered substantially equivalent to the currently marketed predicate device (SCENARIA Phase 2 Whole-body X-ray CT System (K123509)) in terms of design features, fundamental scientific technology, indications for use, and safety and effectiveness.
1 Certified by the Declaration of Conformity with Design Controls in Section 1.
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Summary of Non-Clinical Testing
The SUPRIA system is in conformance with the applicable parts of the following standards:
-
AAMI ANSI ES60601-1:2005/(R) 2012 and A1:2012, C1:2009/(R)2012 and ● A2:2010/(R)2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential
performance (IEC 60601-1:2005, MOD) -
IEC 60601-1-2 Edition 3: 2007 . Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
-
. IEC 60601-1-3 Edition 2.0 2008-01
Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
- IEC 60601-2-44 Edition 3.0 2009-02 . Medical electrical equipment Part 2-44: particular requirements for the basic safety and essential performance of x-ray equipment for computed tomography.
- NEMA XR 25
Computed tomography dose check. (Radiology)
-
. NEMA XR 26
Access Controls for Computer Tomography: Identification, Interlocks, and Logs -
IEC 62304 First edition 2006-05, Medical device software Software life cycle processes 0
In addition, the device complies with all applicable requirements for Dose Profile, Noise, Mean CT number and Uniformity, Spatial Resolution, Tomographic Section Thickness and Sensitivity Profile, Tomographic Plane Location, and CT dose index.
Summary of Clinical Testing
Clinical images were collected and analyzed to ensure that the SUPRIA w/guideShot Option will meet user needs.
As a result of the analysis:
| Testing Type | Rationale Analysis |
|---|---|
| Performance Testing - Clinical | We provide clinical image examples which we judged to be sufficient to judge a clinical usability. |
Conclusions
Hitachi believes that, based on the information included in the submission and the original submission, SUPRIA w/guideShot Option is substantially equivalent with respect to hardware, base elements of the software, safety, effectiveness, and functionality to the SCENARIA Phase 2 Whole-body X-ray CT System (K123509).